FDA.reportPublic FDA data

SONIALVISON G4

Primary DI
04540217041213
Brand
SONIALVISON G4
Company
SHIMADZU CORPORATION
Model
566-10000-22
Published
2018-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04540217041213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04540217041213045402170412134540217041213

GMDN Terms#

Term, Definition table
TermDefinition
Stationary general-purpose fluoroscopic x-ray system, digitalA stationary general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be viewed in both real-time and delayed format.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690558747
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04540217040872SONIALVISION G4503-78000-512019-08-14
04540217040889SONIALVISION G4503-78000-522019-08-14
04540217040896SONIALVISION G4503-78000-532019-08-14
04540217041022SONIALVISION G4566-10000-412019-08-14
04540217041039SONIALVISION G4566-10000-422019-08-14
04540217041046SONIALVISION G4566-10000-432019-08-14
04540217041053SONIALVISION G4566-10000-462019-08-14
04540217041060SONIALVISION G4566-10000-472019-08-14
04540217059539R-20J563-55050-312020-02-21
04540217059553Trinias503-79831-432019-05-31
04540217059607Trinias503-79823-432019-05-31
045402170607880.7/1.2JG326 D-265582-24825-422019-07-23
045402170608250.4/0.7JG326 D-265582-24838-112019-07-23
04540217061006Trinias503-79830-432019-05-31
04540217061099Trinias503-79832-432019-05-31
04540217061136Trinias503-79840-432019-05-31
045402170614260.7/1.2JG326 D-265582-24825-042019-07-23
045402170618840.6/1.2P324DK-85582-24486-502020-02-21
045402170618910.6/1.2P324DK-85582-24486-572020-02-21
045402170620340.6/1.2P13DK-85582-24476-502020-02-21

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